Back to resultsThe Efficacy and Safety of SCTA01 in Hospitalized Patients With Severe COVID-19
Primary Purpose
Covid19
Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SCTA01
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Hospitalized patients with severe COVID-19 (5 point on NIH 8-point ordinal scale).
- Male or female adult ≥18 years of age at time of enrollment;
- Biological samples (not limited to any specific type) collected within 72 hours before randomization is laboratory-confirmed as SARS-CoV-2 infection (PCR or antigen-based diagnostic tests);
- ≤ 10 days since symptoms of COVID-19 onset.
Exclusion Criteria:
- Patients who need non-invasive ventilation or high flow oxygen (i.e., 6 point on the 8-point ordinal scale);
- Patients with critical COVID-19;
- Patients with Severe COVID-19 who received convalescent plasma or COVID-19 vaccine, or anti-SARS-CoV-2 spike (S) protein targeted therapy;
- Alanine-amino transferase (ALT) or aspartate transaminase (AST) is 5 times higher than the upper limit of the normal value;
- Estimated glomerular filtration rate (eGFR) <30 mL/min or on dialysis {eGFR calculated by Cockcroft-Gault formula (Cockcroft DW, 1976), Male: CrCL (mL/min) = [(140 - age) × weight (kg)] × 1/ [SCr (mg/dL) × 72]; Female: CrCL (mL/min) = [(140 - age) × weight (kg)] × 0.85/ [SCr (mg/dL) × 72]}.
Sites / Locations
- SCT study siteRecruiting
- SCT study site
- SCT study site
- SCT study site
- SCT study site
- SCT study site
- SCT study site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
SCTA01 Low Dose+BSC
SCTA01 High Dose+BSC
Placebo+BSC
Arm Description
SCTA01in a lower dose+best supportive care
SCTA01in a higher dose+best supportive care
SCTA01 excipients+best supportive care
Outcomes
Primary Outcome Measures
The clinical efficacy of SCTA01 (Phase II and III)
As assessed by time to clinical improvement (TTCI)
Secondary Outcome Measures
Cumulative incidence of SAEs(Phase II, III)
Cumulative incidence of serious adverse events in both Phase II and III
Change from baseline in viral shedding as measured by RT-qPCR(Phase II and III)
Change from baseline in viral shedding as measured by RT-qPCR in NP swab samples
area under the curve (AUC0-t)(Phase II)
AUC0-t through Day 120
AUC0-∞(Phase II)
AUC0-∞ through Day 120
Half-life time (t1/2)(Phase II)
t1/2 through Day 120
Maximum concentration (Cmax)(Phase II)
Cmax through Day 120
Peak time (Tmax)(Phase II)
Tmax through Day 120
Clearance (CL)(Phase II)
CL through Day 120
Apparent volume of distribution (Vd)(Phase II)
Vd through Day 120
Elimination rate constant (λz)(Phase II)
λz through Day 120
Immunogenicity as measured by anti-drug antibodies (ADA) (Phase II, III)
ADA against SCTA01 at baseline and Day 120
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04644185
Brief Title
The Efficacy and Safety of SCTA01 in Hospitalized Patients With Severe COVID-19
Official Title
A Multicenter, Adaptive, Randomized, Double-blinded, Placebo-controlled Phase II/III Trial to Evaluate the Efficacy and Safety of Monoclonal Antibody SCTA01 Against SARS-CoV-2 in Hospitalized Patients With Severe COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 27, 2021 (Actual)
Primary Completion Date
June 27, 2021 (Anticipated)
Study Completion Date
December 27, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinocelltech Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlled Phase II/III trial, and will be conducted globally. The study is comprised of two parts: dose selection (Phase II) and pivotal treatment effect (Phase III).
Detailed Description
In this study, Phase II part will evaluate the efficacy, safety and PK of SCTA01 low dose+BSC, high dose+BSC and placebo+BSC in patients with severe COVID-19.
In Phase II part, subjects will be randomized at 1:1:1 ratio. At the end of Phase II part, a dose for the Phase III will be determined.
The Phase III part will evaluate the efficacy, safety, and immunogenicity of SCTA01 at the recommended dose recommended. Subjects in Phase III part will be randomized at 1:1 ratio to SCTA01+BSC and placebo+BSC groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
795 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SCTA01 Low Dose+BSC
Arm Type
Experimental
Arm Description
SCTA01in a lower dose+best supportive care
Arm Title
SCTA01 High Dose+BSC
Arm Type
Experimental
Arm Description
SCTA01in a higher dose+best supportive care
Arm Title
Placebo+BSC
Arm Type
Active Comparator
Arm Description
SCTA01 excipients+best supportive care
Intervention Type
Drug
Intervention Name(s)
SCTA01
Other Intervention Name(s)
Recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
Intervention Description
SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
SCTA01 excipients
Intervention Description
all SCTA01 excipients without active component+best supportive care
Primary Outcome Measure Information:
Title
The clinical efficacy of SCTA01 (Phase II and III)
Description
As assessed by time to clinical improvement (TTCI)
Time Frame
Day 29
Secondary Outcome Measure Information:
Title
Cumulative incidence of SAEs(Phase II, III)
Description
Cumulative incidence of serious adverse events in both Phase II and III
Time Frame
3 Months
Title
Change from baseline in viral shedding as measured by RT-qPCR(Phase II and III)
Description
Change from baseline in viral shedding as measured by RT-qPCR in NP swab samples
Time Frame
Day 120
Title
area under the curve (AUC0-t)(Phase II)
Description
AUC0-t through Day 120
Time Frame
Day 120
Title
AUC0-∞(Phase II)
Description
AUC0-∞ through Day 120
Time Frame
Day 120
Title
Half-life time (t1/2)(Phase II)
Description
t1/2 through Day 120
Time Frame
Day 120
Title
Maximum concentration (Cmax)(Phase II)
Description
Cmax through Day 120
Time Frame
Day 120
Title
Peak time (Tmax)(Phase II)
Description
Tmax through Day 120
Time Frame
Day 120
Title
Clearance (CL)(Phase II)
Description
CL through Day 120
Time Frame
Day 120
Title
Apparent volume of distribution (Vd)(Phase II)
Description
Vd through Day 120
Time Frame
Day 120
Title
Elimination rate constant (λz)(Phase II)
Description
λz through Day 120
Time Frame
Day 120
Title
Immunogenicity as measured by anti-drug antibodies (ADA) (Phase II, III)
Description
ADA against SCTA01 at baseline and Day 120
Time Frame
Day 120
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hospitalized patients with severe COVID-19 (5 point on NIH 8-point ordinal scale).
Male or female adult ≥18 years of age at time of enrollment;
Biological samples (not limited to any specific type) collected within 72 hours before randomization is laboratory-confirmed as SARS-CoV-2 infection (PCR or antigen-based diagnostic tests);
≤ 10 days since symptoms of COVID-19 onset.
Exclusion Criteria:
Patients who need non-invasive ventilation or high flow oxygen (i.e., 6 point on the 8-point ordinal scale);
Patients with critical COVID-19;
Patients with Severe COVID-19 who received convalescent plasma or COVID-19 vaccine, or anti-SARS-CoV-2 spike (S) protein targeted therapy;
Alanine-amino transferase (ALT) or aspartate transaminase (AST) is 5 times higher than the upper limit of the normal value;
Estimated glomerular filtration rate (eGFR) <30 mL/min or on dialysis {eGFR calculated by Cockcroft-Gault formula (Cockcroft DW, 1976), Male: CrCL (mL/min) = [(140 - age) × weight (kg)] × 1/ [SCr (mg/dL) × 72]; Female: CrCL (mL/min) = [(140 - age) × weight (kg)] × 0.85/ [SCr (mg/dL) × 72]}.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Qi, PhD
Phone
+86-10-5862 8288
Ext
9360
Email
ji_qi@sinocelltech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhanghua Lan, PhD
Organizational Affiliation
Sinocelltech Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
SCT study site
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucasti
Facility Name
SCT study site
City
Ciudad Autonoma de Buenos aires
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelo
Facility Name
SCT study site
City
Uberlândia
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arantes
Facility Name
SCT study site
City
Talca
Country
Chile
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silva
Facility Name
SCT study site
City
Rionegro
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gomez
Facility Name
SCT study site
City
Monterrey
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mercado Longoria
Facility Name
SCT study site
City
Lima
Country
Peru
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carbajal
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34473343
Citation
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Results Reference
derived
Learn more about this trial
The Efficacy and Safety of SCTA01 in Hospitalized Patients With Severe COVID-19
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